MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 8X18IN 0 S/A CTXB CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	JB724
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances related to the reported complaint condition were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an unknown procedure in (b)(6) 2019, and the suture was used.During the procedure, the needle was detached from the suture easily during use.It was a control release needle.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).It was reported that the device had a pull off - suture needle issue.Three unopened samples of product code jb724, lot pa5056 were returned for analysis.The product code is control release.The complaint sample was not returned.During visual inspection of three unopened samples, no defects were found on the packages.Samples were opened and contains eight strands; the swage and attachment area of the samples were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects or damaged were found.A functional test was performed and the pull force results meet the customer requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the samples received, no performance needle pull off was found, and the tested samples met the finished goods requirements.Representative samples returned to support investigation of 5 device issues captured in reports 2210968-2019-83501, 2210968-2019-83505, 2210968-2019-83506, and 2210968-2019-83507.Analysis results have been included in follow-up reports for each.

• Brand Name: VCL CT BRD UD 8X18IN 0 S/A CTXB CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8749772
• Report Number: 2210968-2019-83504
• Device Sequence Number: 11189584
• Product Code: GAM
• UDI-Device Identifier: 10705031043954
• UDI-Public: 10705031043954
• Combination Product (Y/N): N
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: JB724
• Device Lot Number: PA5056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Received by Manufacturer: 06/09/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 08/05/2019
• Patient Sequence Number: 1